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Implementation of Innovative Treatment for Moral Injury Syndrome: A Hybrid Type 2 Study

Implementation of Innovative Treatment for Moral Injury Syndrome: A Hybrid Type 2 Study

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06230887
Enrollment
200
Registered
2024-01-30
Start date
2024-07-30
Completion date
2028-07-31
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moral Injury Syndrome

Keywords

Moral Injury, Posttraumatic Stress Disorder, Spirituality, chaplains

Brief summary

Moral Injury Syndrome (MIS) affects up to 35-60% of Veterans managing combat-related PTSD; it results from experiences that challenge deeply held values or spiritual beliefs. Symptoms of MIS may include hopelessness, helplessness, loss of spiritual beliefs, difficulty with forgiveness, loss of meaning or purpose, reduced trust in self or others, or intractable guilt, shame or anger. Veterans managing MIS have difficulty responding to mental health treatment, and are at increased risk for suicide ideation or attempts. To date evidence-based interventions for MIS are not widely available in VA. This study will implement an evidence-based intervention for MIS in four VA facilities, collect data on the effectiveness of the intervention, and develop an implementation toolkit. This data will inform national dissemination in collaboration with the Office of Mental Health and Suicide Prevention and the National Chaplain Service.

Detailed description

Background: Moral injury syndrome (MIS) consists of the psychological and behavioral sequelae of experiences that challenge moral, spiritual, or values related beliefs. Symptoms of MIS may include hopelessness, helplessness, loss of previously held spiritual beliefs, struggle with a Higher Power, difficulty with forgiveness, lack of meaning or purpose, reduced trust in self or others, or intractable guilt, shame or anger. Individuals managing MIS are up to twice as likely as their peers to consider and attempt suicide, and derive less benefit from psychotherapy. There are few evidence-based interventions for moral injury; one such intervention is a manualized, group intervention called "Building Spiritual Strength (BSS)." In previous randomized controlled trials BSS has been shown to reduce both symptoms of PTSD and spiritual distress. This clinical trial will be one of the first to measure symptoms of MIS as a primary outcome. Hypotheses are: 1. Compared to Present Centered Group Therapy (PCGT), BSS will significantly decrease symptoms of MIS. 2. Compared to PCGT, BSS will significantly decrease symptoms of PTSD, depression, and suicidal ideation. Significance: To date there are not standard procedures for assessing and treating MIS, so it is likely that untreated MIS is contributing to poor outcomes, including suicides. Developing an implementation toolkit so that BSS is widely available in VA facilities could reduce the impact of MIS on Veterans' mental health. Innovation and Impact: To date there have not been funded implementation studies on treatments for MIS in Veterans, and very few VA facilities provide evidence-based care for MIS. This study can clear the way to make evidence-based care for MIS more accessible in the VA system. Specific Aims: 1. Conduct a mixed methods pre-implementation evaluation to identify barriers and facilitators for BSS implementation at each site, and to develop local implementation strategies. Specific implementation variables assessed, based on the Proctor and EBQI models include acceptability, appropriateness, and feasibility. Specific variables to be assessed will include a) acceptability of BSS to stakeholders, b) available implementation resources, and c) organizational openness to adding a new EBP. 2. Conduct a randomized controlled trial comparing BSS to Present Centered Group Therapy (PCGT) for Veterans who score above cutoff on the Moral Injury Outcomes Scale. Effectiveness and functional outcomes will be informed by the psychospiritual developmental model of MIS. 3. Conduct a mixed methods post-implementation evaluation to compare outcomes across chaplaincy managed vs. mental health managed BSS programs. Proctor model outcomes will include adoption, fidelity, penetration, and sustainability. Specific outcomes related to this framework include a) successful BSS implementation, b) fidelity in implementation of BSS, c) percentage of eligible, referred Veterans who access BSS services, and d) qualitative reports of intent to maintain the BSS program when the study is complete. Methodology: This will be a type 2 hybrid study, combining pre- and post-implementation evaluations with a randomized clinical trial at 4 culturally diverse VA sites. Next Steps and Implementation: Data on barriers and facilitators will be used to develop a toolkit and collaborate with study partners at the Office of Mental Health and Suicide Prevention and the National Chaplain Service to develop a national dissemination plan for BSS. The investigators will work with existing clinical staffing at the study sites, so that those sites can continue to provide BSS services after the study. Furthermore, after completing this study, BSS leaders will be qualified to train BSS leaders at other sites, creating resources for training and national dissemination.

Interventions

BEHAVIORALBuilding Spiritual Strength

Spiritually Integrated group intervention for moral injury

Active control, manualized evidence-based coping skills intervention for PTSD

Sponsors

VA Office of Research and Development
Lead SponsorFED
VA Central Arkansas Health Care System
CollaboratorUNKNOWN
VA Atlanta Healthcare System
CollaboratorUNKNOWN
Michael E. DeBakey VA Medical Center
CollaboratorFED
Minneapolis Veterans Affairs Medical Center
CollaboratorFED
VA Maine Healthcare System
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes assessor will not have access to shared files, and will not be at any team meetings in which individual participants are discussed, so she will not know to what condition the participants have been assigned.

Intervention model description

Participants will be randomized to either the experimental condition (Building Spiritual Strength, an evidence-based, manualized, spiritually integrated group counseling program for moral injury/spiritual distress/values related distress associated with trauma) or the control condition (Present Centered Group Therapy, an evidence-based, manualized group treatment for PTSD.)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Veteran status and: * (a) validation of any of the first three items on the Moral Injury and Distress Scale, which is consistent with probable MIS * (b) willingness to be randomized to either treatment condition * (c) stability on mental health medications for at least 8 weeks * (d) age of 18 years or older

Exclusion criteria

* (a) insufficient capacity to consent * (b) active psychosis or substance use at levels that would interfere with treatment, assessed via chart review, the Alcohol Use Disorders Identification Test - Concise (AUDIT-C) score, and the Mini International Neuropsychiatric Interview (MINI) * (c) currently involved in evidence-based psychotherapy for MIS, or evidence-based psychotherapy for PTSD, assessed via chart review and intake interview * (d) managing any severe psychopathology that, in the opinion of the investigative team, requires immediate clinical attention, such as imminent suicide risk, assessed via the MINI and supplemental homicide risk questions.

Design outcomes

Primary

MeasureTime frameDescription
Change in Moral Injury and Distress Scale8 weeks (end of treatment) and 20 weeks (long-term follow-up)Full Scale Name: Moral Injury and Distress Scale Score Range: 0-90, with higher scores indicating more symptoms.
Change in Moral Injury Outcomes Scale8 weeks (end of treatment) and 20 weeks (long-term follow-up)Full Scale Name: Moral Injury and Distress Scale Score Range: 0-56, with higher scores indicating more symptoms.
Change in Religious and Spiritual Struggles Scale8 weeks (end of treatment) and 20 weeks (long-term follow-up)Full Scale Name: Religions and Spiritual Struggles Scale Score Range: 0=4 with higher scores indicating more symptoms

Secondary

MeasureTime frameDescription
Change in Patient Health Questionnaire-98 weeks (end of treatment) and 20 weeks (long-term follow-up)Full Scale Name: Patient Health Questionnaire-9 Score range: 1-27, with higher scores indicating more symptoms
Change in Sheehan Disability Scale8 weeks (end of treatment) and 20 weeks (long-term follow-up)Full Scale Name: Sheehan Disability Scale Score Range: 0-30, with higher scores indicating more functional disability
Change in Beck Scale for Suicide Ideation8 weeks (end of treatment) and 20 weeks (long-term follow-up)Full Scale Name: Beck Scale for Suicide Ideation Score Range: 0-38, with higher values indicating a greater risk of suicide
Change in Reasons for Living Inventory8 weeks (end of treatment) and 20 weeks (long-term follow-up)Full Scale Name: Reasons for Living Inventory Score Range: 48-288, with higher scores represent more reasons to live.
PTSD Checklist for DSM-58 weeks (end of treatment) and 20 weeks (long-term follow-up)Full Scale Name: PTSD Checklist for DSM-5 Score Range 0-80, with higher numbers indicating greater symptom severity
Client Satisfaction Questionnaire-88 weeks (end of treatment)Full Scale Name: Client Satisfaction Questionnaire-8 Score Range 8-32, with higher numbers indicating greater satisfaction.
Psychospiritual Development Scale8 weeks (end of treatment) and 20 weeks (long-term follow-up)Full Scale Name: Multiscale Measure for Postconventional Spiritual Functioning Score Range measures different reasoning levels and is structured around four distinct subscales rather than a single total score: conventional vs. postconventional levels of religious reasoning, with decisions to be an adherent or a disaffiliate of faith
Spiritual Fortitude Questionnaire8 weeks (end of treatment) and 20 weeks (long-term follow-up)Full Scale Name: Spiritual Fortitude Questionnaire Score Range 9-45, with higher numbers indicating greater spiritual fortitude

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJeffrey M Pyne, MD

Central Arkansas Veterans Healthcare System , Little Rock, AR

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026